Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction
This study has been completed.
Information provided by:
First received: April 8, 2008
Last updated: December 10, 2008
Last verified: December 2008
To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.
||Observational Model: Case-Only
Time Perspective: Prospective
||Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction
Primary Outcome Measures:
- Follicular damage assessed by histology [ Time Frame: first visit ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- Comparison of permanent hair reduction between ET and HS handpieces [ Time Frame: 2 month follow up visit ] [ Designated as safety issue: No ]
Biopsied hair follicles retained and analzed through horizontal sectioning and viability staining
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
5 Adult male subjects that have sought laser back hair removal
- Healthy male adult, 18 years of age or older with skin type I-V;
- Having a suitable treatment area for hair removal with brown or black hair (no gray);
- Able and willing to comply with the treatment/follow-up schedule and requirements;
- Able to read, understand and provide written Informed Consent.
- Showing symptoms of hormonal disorders, as per the Investigator's discretion;
- Use of oral isotretinoin (Accutane®) within 6 months, or off label use of topical isotretinoin in immediate treated area or in its proximity within 3 months, of study enrollment or during the course of the study;
- Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
- Adverse reaction to the treatment gel to be used in the evaluation;
- History of keloid formation or poor wound healing in a previously injured skin area;
- Significant skin conditions affecting treated area or inflammatory skin conditions;
- Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
- Having a bleeding disorder or taking anticoagulation medications within the preceding 6 months;
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated;
- Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
- Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
- Photosensitivity disorder that can be exacerbated by infrared light;
- Tattoos in the treatment areas;
- Dysplastic nevi in the treatment areas;
- Allergy or history of an allergy to the topical anesthetic used.
- Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
- Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
- Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00657085
|San Diego, California, United States |
||Seaver Soon, MD
No publications provided
||Chris Clark, Lumenis
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 8, 2008
||December 10, 2008
||United States: Institutional Review Board
Keywords provided by Lumenis Ltd.:
ClinicalTrials.gov processed this record on July 22, 2014